Download PG0224 Cardioverter Defibrillators

POLICY . . . . . . . . PG-0224
EFFECTIVE . . . . . .06/01/09
LAST REVIEW . . . 01/27/17
MEDICAL POLICY
Cardioverter Defibrillators
GUIDELINES
This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder
contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the
accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure
reporting and does not imply coverage and reimbursement.
DESCRIPTION
Cardioverter defibrillators discussed in this policy are:
1. Transvenous implantable cardioverter defibrillators
2. Subcutaneous implantable cardioverter defibrillators
3. Wearable cardioverter defibrillators
4. Automatic external defibrillators (AED)
Transvenous Implantable Cardioverter Defibrillator
The automatic transvenous implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient’s
heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to
terminate these arrhythmias to reduce the risk of sudden death. Indications for ICD implantation can be broadly
subdivided into:
5. Secondary prevention, i.e., their use in patients who have experienced a potentially life-threatening episode
of VT (near sudden cardiac death)
6. Primary prevention, i.e., their use in patients who are considered at high risk for sudden cardiac death but
who have not yet experienced life-threatening VT or VF
The standard ICD involves placement of a generator in the subcutaneous tissue of the chest wall. Transvenous
leads are attached to the generator and threaded intravenously into the endocardium. The leads sense and
transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces an
electrical shock when a malignant arrhythmia is recognized.
Multiple ICD devices have been approved by the U. S. Food and Drug Administration (FDA) through the Premarket
Approval (PMA) process. Manufacturers of ICD devices include Biotronik (Lake Oswego, OR), Boston Scientific
(Natick, MA), Sorin Group (Arvada, CO), Medtronic (Minneapolis, MN), and St. Jude Medical (St. Paul, MN).
Subcutaneous Implantable Cardioverter Defibrillator
The S-ICD System (Subcutaneous Implantable Cardioverter Defibrillator; Boston Scientific Corp.) is the first
subcutaneous ICD on the market and is designed to monitor and treat cardiac arrhythmias and to reduce the risks
of SCA and sudden cardiac death. The S-ICD System is a new generation of the ICD that does not require
transvenous (TV) insertion; instead, the S-ICD system electrode is inserted under the skin and implanted outside of
the rib cage. The S-ICD System includes an implantable lead, an implantable pulse generator, a lead insertion tool,
and a programming device that communicates wirelessly with the pulse generator. Unlike the conventional TV-ICD,
implantation of the S-ICD does not require fluoroscopy or contrast agents and is usually inserted using local
anesthesia with sedation. The pulse generator is placed in a subcutaneous pocket along the sixth rib in the left
axillary area. When the device detects an arrhythmia, it confirms the finding, charges, and delivers 1 or more 80Joule shocks to the heart. Interrogation of the device allows the cardiologist to assess the history of treated and
untreated episodes of ventricular arrhythmias. The device is inserted by a cardiologist, electrophysiologist, or
cardiac surgeon and patients are generally hospitalized overnight.
Wearable Cardioverter Defibrillator
A wearable cardioverter defibrillator (WCD) is a temporary, external device that is an alternative to an ICD. It is
primarily intended for temporary conditions for which an implantable device is contraindicated, or for a period of
time during which the need for a permanent implantable device is uncertain. A WCD is intended to perform the
same tasks as an ICD, without requiring invasive procedures. It consists of a vest that is worn continuously
underneath the patient's clothing. Part of this vest is the “electrode belt” that contains the cardiac monitoring
electrodes and the therapy electrodes that deliver a counter shock. The vest is connected to a monitor with a
battery pack and alarm module that is worn on the patient’s belt. The monitor contains the electronics that interpret
the cardiac rhythm and determines when a counter shock is necessary. The alarm module alerts the patient to
certain conditions by lights or voice messages.
The U.S. Food and Drug Administration (FDA) gave clearance to the Lifecor WCD® 2000 system via premarket
application approval in December 2001 for "Adult patients who are at risk for sudden cardiac arrest and are either
not candidates for or refuse an implantable defibrillator." The trade name of the WCD 2000 System was changed to
LifeVest™ in 2002, and the LIFECOR business was acquired by ZOLL Medical Corporation (Philadelphia, PA) in
2006.
Automated external defibrillators (AED)
Automated external defibrillators (AED) are portable electronic devices that allow minimally trained individuals to
provide electric shock to prevent death due to sudden cardiac arrest. These devices monitor heart rhythm and can,
if needed, deliver an electric shock to the chest wall much like a traditional (paddle) defibrillator in a hospital.
POLICY
HMO, PPO, Individual Marketplace, Elite
Wearable cardioverter defibrillators (K0606) require prior authorization.
Transvenous implantable cardioverter defibrillators (33216-33218, 33220, 33223-33225, 33230, 33231, 33240,
33241, 33243, 33244, 33249, 33262-33264, 93745) & subcutaneous implantable cardioverter defibrillators
(33270, 33271, 33272, 33273, 93260, 93261, & 93644) do not require prior authorization.
HCPCS codes K0607-K0609 do not require prior authorization.
Automatic external defibrillators (AED) (E0617) do not require prior authorization.
Advantage
Wearable cardioverter defibrillators (K0606) require prior authorization.
Transvenous implantable cardioverter defibrillators (33216-33218, 33220, 33223-33225, 33230, 33231, 33240,
33241, 33243, 33244, 33249, 33262-33264, 93745) & subcutaneous implantable cardioverter defibrillators
(33270, 33271, 33272, 33273, 93260, 93261, & 93644) do not require prior authorization.
HCPCS codes K0607-K0609 are non-covered.
Automatic external defibrillators (AED) (E0617) are non-covered.
Paramount covers wearable cardioverter defibrillators (LifeVest) when it is medically necessary for:
1. Patients who have an ICD placed for secondary prevention and that ICD is either removed for infection or
malfunctioning
2. Patients who have an ICD and have received appropriate therapy from the device, and that ICD is either
removed for infection or malfunctioning
3. Patients who have suffered a cardiac arrest or hemodynamically significant ventricular arrhythmias and
cannot have an ICD placed because of infection or vascular issues
4. Patients with high-risk features such as syncope and-or structural or genetic cardiomyopathies, in whom
ventricular arrhythmias are strongly suspected
Paramount may strongly consider coverage for wearable cardioverter defibrillators (LifeVest) for:
1. Patients who have a markedly depressed ejection fraction (EF) (certainly < 35%); this patient population is
known to receive more appropriate shocks in large ICD trials
2. Patients who have long runs of symptomatic nonsustained ventricular tachycardia (NSVT) that falls short of
being hemodynamically unstable or causing syncope
3. Patients who suffered cardiogenic shock as part of their initial presentation with a depressed EF
4. Patients who had a large anterior wall MI either in the past or as part of their presentation
Paramount considers FDA approved transvenous implantable cardioverter defibrillators and subcutaneous
implantable cardioverter defibrillators medically necessary when:
1. Sudden cardiac death survivors from spontaneously occurring ventricular fibrillation and ventricular
tachycardia OR
2. Spontaneously occurring syncopal (hypotensive) ventricular tachycardia and .structural heart disease OR
3. Unexplainable syncope, by history and clinical circumstances due to a symptomatic ventricular
tachyarrhythmia in the presence of structural heart disease OR
4. Cardiomyopathy with EF (ejection fraction) <35% and at least 40 days post myocardial infarction, or 90
days post revascularization (stent or bypass) OR
5. Symptomatic cardiomyopathy with EF <35% treated for at least 3 months with optimal medical therapy OR
6. Familial or inherited conditions with high risk of life threatened Ventricular Tachyarrhythmia, ex: prolong
QT Syndrome or Hypertrophic Cardiomyopathy, sarcoidosis, Chagas disease, scleroderma, myotonic
dystrophy and other conditions known to increase the risk of sudden cardiac death.
Above approved if not due to remediable causes, or neither controlled by appropriate drug therapy nor amenable to
definitive therapy AND
Patients must not have the following:
1. New York Heart Association Class IV Cardiogenic Shock or Symptomatic Hypotension while in a stable
baseline rhythm
2. CABG or PTCA within past 3 months, unless there is pacing indication
3. Acute MI in last 40 days
4. Clinical symptoms or findings to make them a candidate for revascularization
5. Irreversible brain damage (Glasgow coma scale ≤ 3)
6. Any disease, other than Cardiac Disease, with likelihood of survival less than 1 year
7. Ventricular tachycardia amenable to medical and or ablative treatment
8. Syncope in the absence of structural heart disease.
HMO, PPO, Individual Marketplace, Elite
An automatic external defibrillator (E0617) is covered if a previously implanted defibrillator now requires
explantation OR the member has one of the following conditions AND implantation surgery is contraindicated:
1. A documented episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible
cause
2. A sustained, lasting 30 seconds or longer, ventricular tachyarrhythmia, either spontaneous or induced
during an electrophysiologic (EP) study, not associated with acute myocardial infarction, and not due to a
transient or reversible cause
3. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrythmias such as long
QT syndrome or hypertrophic cardiomyopathy
4. Coronary artery disease with a documented prior myocardial infarction with a measured left ventricular
ejection fraction less than or equal to 0.35, and inducible, sustained ventricular tachycardia (VT) or
ventricular fibrillation (VF) during an EP study. To meet this criterion;
a. The myocardial infarction must have occurred more than 4 weeks prior to the external defibrillator
prescription; and,
b. The EP test must have been performed more than 4 weeks after the qualifying myocardial
infarction.
5. Documented prior myocardial infarction and a measured left ventricular ejection fraction less than or equal
to 0.30. Member must not have:
a. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or,
b. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty
(PTCA) within past 3 months; or,
c. Had an enzyme-positive MI within past month; or,
d. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or,
e. Irreversible brain damage from preexisting cerebral disease; or,
f. Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a
likelihood of survival less than one year.
6. Members with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New
York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction
(LVEF) ≤ 35%.
7. Members with nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart
failure, and measured LVEF ≤ 35%
8. Members who meet one of the previous criteria (1-7) and have NYHA Class IV heart failure
A family member must get certified with basic CPR for an automatic external defibrillator (E0617) to be covered.
Replacement supplies and accessories for use with K0606 are coded using K0607-K0609 as appropriate.
Advantage
HCPCS codes K0607-K0609 are non-covered.
Automatic external defibrillators (AED) (E0617) are non-covered.
CODING/BILLING INFORMATION
The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria
that must be met. Payment for supplies may be included in payment for other services rendered.
HCPCS CODES
C1721 Cardioverter-defibrillator, dual chamber (implantable)
C1722 Cardioverter-defibrillator, single chamber (implantable)
C1777 Lead, cardioverter-defibrillator, endocardial single coil (implantable)
C1882 Cardioverter-defibrillator, other than single or dual chamber (implantable)
C1895 Lead, cardioverter-defibrillator, endocardial dual coil (implantable)
C1896 Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable)
C1899 Lead, pacemaker/cardioverter-defibrillator combination (implantable)
E0617 External defibrillator with integrated electrocardiogram analysis
K0606 Automatic external defibrillator, with integrated electrocardiogram analysis, garment type
K0607 Replacement battery for automated external defibrillator, each
K0608 Replacement garment for use with automated external defibrillator, each
K0609 Replacement electrodes for use with automated external defibrillator, each
CPT CODES
33216 Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator
33217 Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator
33218 Repair of single transvenous electrode, permanent pacemaker or implantable defibrillator
33220 Repair of 2 transvenous electrodes for permanent pacemaker or implantable defibrillator
33223 Relocation of skin pocket for implantable defibrillator
33224 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed
pacemaker or pacing implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or
replacement of existing generator)
33225 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator
or pacemaker pulse generator (eg, for upgrade to dual chamber system) (List separately in addition to code for primary
procedure)
33230 Insertion of implantable defibrillator pulse generator only; with existing dual leads
33231 Insertion of implantable defibrillator pulse generator only; with existing multiple leads
33240 Insertion of implantable defibrillator pulse generator only; with existing single lead
33241 Removal of implantable defibrillator pulse generator only
33243 Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by thoracotomy
33244 Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by transvenous extraction
33249 Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual
chamber
33262 Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead
system
33263 Removal of implantable defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator;
dual lead system
33264 Removal of implantable defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator;
multiple lead system
33270 Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including
defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming
or reprogramming of sensing or therapeutic parameters, when performed
33271 Insertion of subcutaneous implantable defibrillator electrode
33272 Removal of subcutaneous implantable defibrillator electrode
33273 Repositioning of previously implanted subcutaneous implantable defibrillator electrode
93260 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the
device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified
health care professional; implantable subcutaneous lead defibrillator system
93261 Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care
professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead
defibrillator system
93282 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the
device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified
health care professional; single lead transvenous implantable defibrillator system
93283
93284
93287
93289
93292
93295
93296
93640
93641
93642
93644
93745
Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the
device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified
health care professional; dual lead transvenous implantable defibrillator system
Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the
device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified
health care professional; multiple lead transvenous implantable defibrillator system
Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery,
procedure, or test with analysis, review and report by a physician or other qualified health care professional; single, dual, or
multiple lead implantable defibrillator system
Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care
professional, includes connection, recording and disconnection per patient encounter; single, dual, or multiple lead
transvenous implantable defibrillator system, including analysis of heart rhythm derived data elements
Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care
professional, includes connection, recording and disconnection per patient encounter; wearable defibrillator system
Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead implantable defibrillator system with
interim analysis, review(s) and report(s) by a physician or other qualified health care professional
Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system or implantable
defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and
distribution of results
Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation
threshold evaluation (induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination) at time of initial
implantation or replacement;
Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator leads including defibrillation
threshold evaluation (induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination) at time of initial
implantation or replacement; with testing of single or dual chamber pacing cardioverter-defibrillator pulse generator
Electrophysiologic evaluation of single or dual chamber pacing cardioverter-defibrillator (includes defibrillation threshold
evaluation, induction of arrhythmia, evaluation of sensing and pacing for arrhythmia termination, and programming or
reprogramming of sensing or therapeutic parameters)
Electrophysiologic evaluation of subcutaneous implantable defibrillator (includes defibrillation threshold evaluation, induction
of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or
therapeutic parameters)
Initial set-up and programming by a physician or other qualified health care professional of wearable cardioverter-defibrillator
includes initial programming of system, establishing baseline electronic ECG, transmission of data to data repository, patient
instruction in wearing system and patient reporting of problems or events
TAWG REVIEW DATES: 01/13/2005, 07/05/2006, 09/20/2007, 10/08/2008, 01/13/2010,
03/09/2011, 04/11/2012, 08/22/14, 09/17/2015, 09/23/2016, 01/27/2017
REVISION HISTORY EXPLANATION
08/22/14: Changed title from Wearable Cardioverter Defibrillator to Cardioverter Defibrillators. Added codes for
ICD: C1721, C1722, C1777, C1882, C1895, C1896, C1899, 33216, 33217, 33218, 33220, 33223, 33224, 33225,
33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262, 33263, 33264, 93282, 93283, 93284, 93287, 93289,
93295, 93296, 93640, 93641, 93642. Added codes for S-ICD: 0319T, 0320T, 0321T, 0323T, 0325T, 0326T,
0327T, 0328T. Added more codes for wearable cardioverter defibrillators: 93292 & 93745. TAWG committee
determined that subcutaneous implantable cardioverter defibrillators (0319T, 0320T, 0321T, 0323T, 0325T, 0326T,
0327T, 0328T) are covered without prior authorization for all product lines. Policy reviewed and updated to reflect
most current clinical evidence per The Technology Assessment Working Group (TAWG).
04/14/15: Removed deleted 12/31/14 codes 0319T, 0320T, 0321T, 0323T, 0325T, 0326T, 0327T, & 0328T. Added
effective 1/1/15 new codes 33270, 33271, 33272, 33273, 93260, 93261, & 93644. 2015 code description revisions
made to 33216-33220, 33223-33225, 33230, 33231, 33240, 33241, & 33262-33264, 93282-93284, 93287, 93289,
93295, & 93296. Wearable cardioverter defibrillators (K0606) now require prior authorization. Policy reviewed and
updated to reflect most current clinical evidence per Medical Policy Steering Committee.
09/17/15: Policy reviewed and updated to reflect most current clinical evidence per The Technology Assessment
Working Group (TAWG).
09/23/16: Codes K0607-K0609 (replacement supplies and accessories for use with K0606) and automatic external
defibrillators (AED) (E0617) are now covered for HMO, PPO, Individual Marketplace, Elite per CMS guidelines. Policy
reviewed and updated to reflect most current clinical evidence per The Technology Assessment Working Group
(TAWG).
01/27/17: Criteria for wearable cardioverter defibrillators (LifeVest) changed from <25% to <35% ejection fraction
(EF) requirement. Policy reviewed and updated to reflect most current clinical evidence per The Technology
Assessment Working Group (TAWG).
REFERENCES/RESOURCES
Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services
Ohio Department of Medicaid http://jfs.ohio.gov/
American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services
Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release
and Code Sets
Industry Standard Review
Hayes, Inc.